The safety of renal denervation as assessed by optical coherence tomography: pre- and post-procedure comparison with multi-electrode ablation catheter in animal experiment

Abstract

ObjectiveTo prove the effectiveness and safety of multi-electrode ablation catheter in renal denervation (RDN) by optical coherence tomography (OCT). MethodsSixteen renal arteries were enrolled from 8 pigs. Angiography and OCT were performed to analyze the morphological changes before RDN and at 1-month follow-up. Blood pressure and creatinine were measured to prove the effectiveness and safety of the catheter. ResultsOne renal artery was excluded because of the small diameter. Fifteen renal arteries successfully underwent renal denervation and OCT. Mean blood pressure was significantly reduced at 1 month after RDN (122.40 ± 3.54 mmHg vs. 106.50 ± 2.06 mmHg, n = 8, P < .001). Creatinine follow-up after 1 month showed no significant change (45.37 ± 7.44 vs. 65.87 ± 49.20 μmol/L, n = 8, P = 0.275). The minimal lumen diameter showed that the renal artery immediately narrowed after the procedure (7.17 ± 0.60 mm vs. 5.93 ± 0.97 mm, n = 15, P < .001). Vasospasm, vascular wall edemas, and thrombus formations all showed significant changes after the procedure except renal artery dissection (0% vs. 21.4%, P = 0.067) under the OCT. Adverse event as renal artery occluded showed no significant difference (0% vs. 6.7%, P > .05). OCT results showed no significant difference in vasospasm, dissections, wall edemas, and thrombus formations (P > .05) at 1 month after the procedure. ConclusionThis multi-electrode ablation catheter could cause minor injury to renal artery instantly after RDN, but it is found to be safe in the animal model at 1-month follow-up.